Morphine Sulfate 5 mg per 0.25 mL Oral Syringe recall — Class II (D-0254-2025) · pharmaranks
Class IIOngoing
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe recall
FDA recall D-0254-2025 · initiated Feb 17, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Details
Product
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
Recalling company
Safecor Health, LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Feb 17, 2025
FDA report date
Mar 12, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.